What is astodrimer?

Astodrimer gel has also been studied for treating bacterial vaginosis.4,5,6 Bacterial vaginosis is an infection that causes unwanted growth of certain bacteria in the vagina. The U.S. Food and Drug Administration (FDA) is currently evaluating whether to approve astodimer to treat and prevent bacterial vaginosis.7

How do topical microbicides work?

Topical microbicides come in many different forms, including gels, creams, films, and vaginal rings (also called an intravaginal ring or IVR). These products are designed to prevent HIV infection during sex, so they are used close to where HIV might enter the body during sexual activities—either the vagina or rectum.9,10 Researchers have studied astrodimer as a gel for vaginal use.3

Topical microbicides may also be called topical pre-exposure prophylaxis (PrEP) products.9 PrEP means using a medicine before possible exposure to a virus or bacteria to reduce the risk of becoming infected with the virus or bacteria. For more information on PrEP, see the AIDSinfoPre-Exposure Prophylaxis (PrEP) fact sheet.

Which clinical trials are studying astodrimer?

Study Names: (1) MTN-004; NCT00442910, and (2) ATN 062; NCT00490152Phase: These studies were Phase I studies.Status: These studies have been completed.Locations: United States and Puerto RicoPurpose: The purpose of MTN-004 was to evaluate the safety and acceptability of astodrimer vaginal gel in sexually active women who did not have HIV. ATN 062 was conducted simultaneously with MTN 004 to further evaluate the acceptability of astodrimer vaginal gel in MTN-004 study participants.11,12

Study Names: SPL7013-004; NCT00331032Phase: IStatus: This study has been completed.Locations: United States and KenyaPurpose: The purpose of this study was to evaluate the safety and tolerability of astodrimer vaginal gel in women who did not have HIV or any other sexually transmitted infections (STIs). The women were sexually active but agreed to abstain from sex during the study.13

Study Names: SPL7013-003; NCT00740584Phase: I/IIStatus: This study has been completed.Location: Australia.Purpose: The purpose of this study was to evaluate the antiviral activity of astodrimer vaginal gel in women who did not have HIV or any other STIs.14

What side effects might astodrimer cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in the studies of astodrimer listed above.

MTN-004 (NCT00442910):
In this study, the most common genital side effects associated with astodrimer were painful sexual intercourse, bleeding or spotting between menstrual periods, and burning or itching of the vagina or vulva.15

SPL7013-004 (NCT00331032):
In this study, side effects related to astodrimer gel use were mostly mild. Two participants stopped using the gel because of a genitourinary (GU) side effect related to the product. Signs suggestive of genital irritation were more common in participants using the astodrimer gel than in participants using a placebo.16

SPL7013-003 (NCT00740584):
Among 4 participants who received at least 1 dose of astodrimer gel, 7 GU side effects were reported. Two of the 7 side effects—mild irritation in the area between the genitals and the anus and moderately severe bacterial vaginosis—were likely related to the astodrimer gel. Three participants had mild symptoms of a vaginal yeast infection possibly related to astodrimer gel exposure.3,14

Information on possible side effects of astodrimer is not complete. As testing of astodrimer continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying astodrimer?

More information about astodrimer-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.

References

References

United States National Library of Medicine. ChemIDplus Advanced. Available at: https://chem.nlm.nih.gov/chemidplus/rn/1379746-42-5. Last accessed on June 29, 2018.

National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Available at: https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Last accessed on June 29, 2018.

Starpharma Pty Ltd. A Phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 gel to prevent the recurrence of bacterial vaginosis. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 5, 2014. NLM Identifier: NCT02237950. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02237950. Last accessed on June 29, 2018.

Starpharma Pty Ltd. A Phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 gel to prevent the recurrence of bacterial vaginosis. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 5, 2014. NLM Identifier: NCT02236156. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02236156. Last accessed on June 29, 2018.

Starpharma: News release, dated April 30, 2018. Starpharma completes US new drug application for VivaGel® BV. Available at: http://www.starpharma.com/news/366#article366. Last accessed on June 29, 2018. [Archived at WebCite]

National Institute of Allergy and Infectious Diseases (NIAID). Microbicides to block transmission of HIV. Available at: https://www.niaid.nih.gov/diseases-conditions/microbicides. Last accessed on June 29, 2018.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Microbicide-use adherence, acceptability, and attitudes among sexually active young women participating in a Phase I microbicide trial (MTN 004) "Tell Juliana". In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 21, 2007. NLM Identifier: NCT00490152. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00490152. Last accessed on June 29, 2018.

National Institute of Allergy and Infectious Diseases (NIAID). An expanded Phase I randomized placebo controlled trial of the safety and tolerability of 3 percent w/w SPL7013 gel (VivaGel™) in healthy young women when administered twice daily for 14 days. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 25, 2006. NLM Identifier: NCT00331032. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00331032. Last accessed on June 29, 2018.

Starpharma Pty Ltd. Assessment of local retention and duration of activity of SPL7013 following vaginal application of 3% SPL7013 gel (VivaGel) in healthy volunteers. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 21, 2008. NLM Identifier: NCT00740584. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00740584. Last accessed on June 29, 2018.